Recently, the U.S. Food and Drug Administration (FDA) released a warning about the risk of EpiPen® autoinjector errors resulting from device malfunctions and user administration. The good news is that EpiPens® are not being recalled, but there is some new safety information you should know if you or a loved one use this life-saving device.
What is an EpiPen®?
An EpiPen® is an auto-injector that contains a medicine called epinephrine. Epinephrine is a medication used when someone is having an allergic reaction (a.k.a., anaphylaxis). It is necessary for severe allergies to insect bites (e.g., bees in the summertime!), foods (e.g., shellfish, peanuts), latex, or other causes.
An auto-injector is a convenient device for patients to use anywhere when they are experiencing an allergic reaction. Patients or loved ones who are trained to use the device can quickly administer a dose of epinephrine to help the affected individual breathe better while they wait for emergency medical services.
The FDA first announced an epinephrine auto-injector shortage back in May 2018, citing manufacturing delays. High demand drove up the price, so even if families could find the product at all (which was hard to do), they would pay much more than usual. Sometimes even hundreds of dollars per device!
Fortunately, other epinephrine products have come to market since then to ease the burden, including authorized generic versions improving affordability and access. Also, the FDA extended expiration dates on some existing products. Epinephrine auto-injector shortages may not be as common, but these products are still active on the FDA shortage list.
New, Important Information – Device Malfunctions and User Administration Errors
The FDA put out an alert to patients and healthcare professionals on March 24, 2020, about both brand and generic EpiPen® (epinephrine) 0.3 mg and 0.15 mg auto-injectors. The alert describes potential device malfunctions and user administration errors.
Note: not all devices and users will have these issues; these are rare but still important to know about as they may prevent or delay emergency treatment
The potential malfunctions are related to the blue safety release, which is underneath the cap on the opposite side of the orange tip containing the needle. See “How to use an EpiPen®“ or EpiPen® patient information for detailed pictures, diagrams, and instructions.
Possible Device Malfunctions:
1. Difficulty getting the device out of the carrier tube. This is due to a slight deformation on the rim of the carrier tube. It does not impact the medication but may delay treatment if the user is having difficulty accessing the device
2. Blue safety release removed using sideway force (rather than pulling straight up). This can happen, for example, if someone does this action with one hand instead of two. It can lead to spontaneous activation of the device.
3. Blue safety release raised. When not in use, the blue safety release should be down into the device (see pictures). If the blue safety release is raised it can lead to spontaneous activation of the device.
User Administration Errors:
1. Forgetting to remove the blue safety release. The device will not work with the safety release in place.
2. Incorrect placement: the device must be administered in the correct location before and during activation. The right dose will not be administered if the directions are not followed closely. See “How to use an EpiPen®“ or EpiPen® patient information for more details. You may also consult your pharmacist or primary care provider for further instruction and training.
- Do not throw away your EpiPen® – in most instances they are still safe to use.
- Inspect your product – Ensure the device can easily be removed from the carrier tube and check to see that the blue safety release is not raised before the device is needed.
- If you find an issue with your auto-injector, you can contact Mylan Customer Relations by phone at 800-796-9526 and a replacement will be provided by the manufacturer at no additional cost.
- Know before you go – Make sure you and your loved ones are aware of these potential auto-injector issues, how to prevent them, and what to do if they happen.
- Practice makes perfect –The FDA recommends periodically reviewing user instructions and practicing with the provided training device to ensure you know how to use the device before it is needed.
- Speak up – Talk to your pharmacist or primary care provider if you have any questions or concerns about this new information, such as what to do in the event of a spontaneous activation. You can also check the FDA website for the most up-to-date alerts and recommendations.
1. FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration. U.S. Food & Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/fda-alerts-patients-and-health-care-professionals-epipen-auto-injector-errors-related-device. Updated April 10, 2020. Accessed June 26, 2020.
2. Epinephrine Injection. MedlinePlus, U.S. National Library of Medicine. https://medlineplus.gov/druginfo/meds/a603002.html. Updated November 15, 2018. Accessed June 26, 2020.
3. Epinephrine Injection, Auto-Injector. FDA Drug Shortages, U.S. Food & Drug Administration. https://www.accessdata.fda.gov/scripts/drugshortages/dsp_ActiveIngredientDetails.cfm?AI=Epinephrine%20Injection,%20Auto-Injector&st=c#. Published May 9, 2018. Updated June 25, 2020. Accessed June 26, 2020.
4. FDA approves first generic version of EpiPen. U.S. Food & Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-version-epipen. Published August 16, 2018. Accessed June 26, 2020.
5. Search List of Extended Use Dates to Assist with Drug Shortages. U.S. Food & Drug Administration. https://www.fda.gov/drugs/drug-shortages/search-list-extended-use-dates-assist-drug-shortages. Updated May 29, 2020. Accessed June 26, 2020.
6. How to use an EpiPen®. Mylan. https://www.epipen.com/-/media/epipencom/assets/pdf/epi_2020_0273_us_howtousepdf.pdf?la=en. Published 2020. Accessed June 26, 2020.
7. EPIPEN- epinephrine injection patient information. DailyMed, U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?type=display&setid=7560c201-9246-487c-a13b-6295db04274a#section-14. Updated January 2020. Accessed June 26, 2020.
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Chris is one of the Co-Founders of Allergies.org. An entrepreneur at heart, Chris has been building and writing in consumer health for over 10 years. In addition to Diabetic.org, Chris and his Acme Health LLC Brand Team own and operate USARx.com, Diabetic.org, Pharmacists.org.
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